Comparative Study on the Efficacy and Safety of Procaterol Versus Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room

March 22, 2010 updated by: Otsuka Pharmaceutical, Inc., Philippines

Comparative Study on the Efficacy and Safety of Procaterol vs Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room

To compare the efficacy and safety of inhaled procaterol (Meptin Air) versus inhaled salbutamol as metered dose inhaler (MDI) reliever of acute exacerbation of asthma not in imminent respiratory failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Manila, Philippines
        • Philippine General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients aged 20 years old and above who are brought to the Emergency Room (ER) with acute bronchospasm
  • Diagnosed cases of bronchial asthma based on history, physical examination and pulmonary function test
  • Patients maintained on inhaled steroids who have no active medical problems (such as pulmonary TB, cardiac and renal diseases) aside from asthma
  • Presence of known risk factors for asthma mortality does not disqualify patients from the study unless they are in impending respiratory failure
  • All patients must sign the informed consent form

Exclusion Criteria:

  • Patients who are in respiratory distress consistent with severe exacerbation requiring intensive care hospital admission
  • Who had intake of oral bronchodilator 6 hrs prior to consult
  • Who had intake of oral steroids within the last 24 hrs
  • Those with positive history of allergy and hypersensitivity to procaterol and salbutamol
  • Patients who are diagnosed or clinically suspected to have COPD (ever-smokers with >10 pack-years smoking history or those exposed to workplaces where there is a heavy smoke load)
  • Presence of concurrent disease/diseases that may aggravate asthma thereby delaying bronchodilator response (e.g., pneumonia, pulmonary congestion and others)
  • Patients with other medical conditions which are serious enough to warrant immediate concurrent therapy during the 1 hour study and/or whose condition can be adversely affected by the treatment given (like uncontrolled diabetes, renal failure and hepatic insufficiency)
  • The NIH Working Group on Asthma and Pregnancy has recommended that pregnant asthmatics are treated as aggressively as non-pregnant patients particularly during acute asthmatic attack. , Bronchodilators (except for epinephrine which is not in this study) have been found safe in pregnancy with a risk class of B and C. For these reasons, pregnancy by itself is not an exclusion criterion in this study and a pregnancy test will not be required for those who are in the childbearing age group. Requiring the test will unnecessarily delay the treatment for acute asthma. However, those who are suspected to be suffering from pregnancy-related complications like vaginal bleeding, premature labor, pre-eclampsia and others, are excluded.

  • Severe Acute Asthma Attack, a reason for patient exclusion, shall be defined in this study as the presence of any one of the following criteria:

    1. Severe asthma with a lack of response to initial therapy in the emergency department or worsening asthma despite adequate therapy.
    2. Presence of confusion, drowsiness, other signs of impending respiratory arrest, or loss of consciousness
    3. Wood-Downe's clinical asthma scoring score of >5 (see table 2 below)
  • Any patient who is currently participating in other drug trials and/or having participated in other drug trials for less than 1 month of termination of the trial are excluded
  • Patients who have previously participated in this study are excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procaterol

Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes

+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment
Drug: Procaterol

Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes

+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment

Other Names:
  • Meptin Air
Active Comparator: Salbutamol
Salbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment
Drug: Salbutamol
Salbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment
Other Names:
  • Ventolin Inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the bronchodilator efficacy of inhaled procaterol (Meptin Air) vs. inhaled salbutamol used as MDI reliever of acute exacerbation of asthma in the ER.
Time Frame: < 12 hours
< 12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of procaterol MDI (Meptin Air) versus salbutamol MDI in the management of acute exacerbation of asthma in terms of adverse side effects such as palpitations, tachycardia, tremor, and hypokalemia.
Time Frame: < 12 hours
< 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical, Inc., Philippines

Investigators

  • Principal Investigator: Camilo Roa, MD, Philippine General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 22, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOIAA-MPT-2005-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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